Senior Manager, Quality Assurance
美国 - 加利福尼亚州 - 福斯特市质量正式员工职位描述
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality organization. This position is dedicated to managing and supporting the Gilead Global Quality Agreement Program.
This position will have high visibility throughout the PDM organization as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program and will collaborate with key internal partners & stakeholders to establish and maintain an effective Global Quality Agreement Program. This position will serve as the primary subject matter expert (SME) for matters related to Quality Agreement content, Quality Agreement lifecycle management, Quality Agreement negotiations, management of Quality Agreement templates in compliance with applicable laws and regulatory requirements, and supporting continuous improvement initiatives related to the Global Quality Agreement Program.
Job Responsibilities
Serves as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program, ensuring the program is compliant, consistent, and effectively implemented across the organization
Develops, maintains, and continuously improves standardized Quality Agreement templates, guidance documents, training materials, and related tools to align with global regulatory requirements and internal policies
Serves as the primary subject matter expert (SME) for Quality Agreement content, interpretation, and applicability across internal teams and external partners, which may include supporting internal stakeholders during review, negotiation, implementation, enforcement, and periodic review of Quality Agreements.
Drives alignment and resolution of complex Quality Agreement terms through collaboration with Legal, Sourcing, and External Quality stakeholders
Establishes and maintains governance processes, metrics, and reporting for the Global Quality Agreement Program to ensure transparency and effectiveness
Monitors regulatory trends and evolving expectations related to Quality Agreements and proactively updates program requirements and templates accordingly
Provides expert support during inspections and audits related to Quality Agreements, including preparation, defense, and remediation activities
Leads or contributes to continuous improvement initiatives to enhance Quality Agreement processes, reduce cycle times, and improve compliance and user experience
Supports training and knowledge-sharing activities to ensure consistent understanding and application of Quality Agreement requirements across the organization
The best candidate...
Demonstrates expertise in Quality Agreements, including development, negotiation, lifecycle management, and governance in a global GMP environment
Demonstrates strong working knowledge of global regulatory requirements applicable to Quality Agreements (e.g., FDA, EMA, ICH) and ability to translate requirements into compliant contract content
Demonstrates strong technical writing skills with the ability to draft, review, and standardize Quality Agreement templates and supporting documentation
Demonstrates advanced stakeholder management, influencing, and negotiation skills across cross-functional and external partner environments
Demonstrates ability to manage and support complex, high-visibility programs with multiple concurrent deliverables and competing priorities
Demonstrates strong communication skills, including the ability to clearly articulate Quality Agreement expectations to internal stakeholders and external partners
Demonstrates the ability to learn quickly and operate effectively in a fast-paced, highly regulated environment
Requirements
8+ years of relevant experience in a GMP environment related field and a BS or BA OR
6+ years of relevant experience in a GMP environment related field and a MA/MS OR
2+ years of relevant experience in a GMP environment related field and a PhD/PharmD
Preferred Knowledge
Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners is preferred
Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight is beneficial and preferred
Experience managing global programs or serving as a Global Process Owner (GPO) is beneficial
Familiarity with digital tools or systems supporting document management, contract lifecycle management, or Quality Agreement tracking is beneficial
Experience and working knowledge with digital Quality Management Systems and Quality Document Management Systems, particularly Veeva Vault, is beneficial..
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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